Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2026-03-05 @ 7:23 AM
Study NCT ID:
NCT01503112
Status:
COMPLETED
Last Update Posted:
2018-04-19
First Post:
2011-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Response to Incretin Based Agents in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Extracted DNA, stored serum/plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 957}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2011-12-30', 'studyFirstSubmitQcDate': '2011-12-30', 'lastUpdatePostDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycaemic response (HbA1c change post treatment)', 'timeFrame': '6 months', 'description': 'Change in HbA1c over 6 months treatment (as a continuous variable and/or defined as binary response/non response). Our Primary analysis will be the relationship between insulin secretion (as measured by blood C-peptide or UCPCR) and glycaemic response. Secondary analysis will include examination of relationship between baseline weight, HbA1c, age, duration of diabetes, HOMA B, HOMA IR, autoantibody (GAD, IA2) status and glycaemic response. We will also examine the relationship between glycaemic response and polymorphisms in GLP-1R, TCF7L2, WFS1 and FOX01 genes.'}], 'secondaryOutcomes': [{'measure': 'Weight change over 6 months treatment', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glucagon-Like Peptide 1, DPP4 protein, Therapeutics, Hypoglycemic Agents, C-Peptide, Type 2 Diabetes Mellitus,'], 'conditions': ['Type2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '26242184', 'type': 'RESULT', 'citation': 'Jones AG, McDonald TJ, Shields BM, Hill AV, Hyde CJ, Knight BA, Hattersley AT; PRIBA Study Group. Markers of beta-Cell Failure Predict Poor Glycemic Response to GLP-1 Receptor Agonist Therapy in Type 2 Diabetes. Diabetes Care. 2016 Feb;39(2):250-7. doi: 10.2337/dc15-0258. Epub 2015 Aug 4.'}, {'pmid': '29386249', 'type': 'RESULT', 'citation': 'Dennis JM, Shields BM, Hill AV, Knight BA, McDonald TJ, Rodgers LR, Weedon MN, Henley WE, Sattar N, Holman RR, Pearson ER, Hattersley AT, Jones AG; MASTERMIND Consortium. Precision Medicine in Type 2 Diabetes: Clinical Markers of Insulin Resistance Are Associated With Altered Short- and Long-term Glycemic Response to DPP-4 Inhibitor Therapy. Diabetes Care. 2018 Apr;41(4):705-712. doi: 10.2337/dc17-1827. Epub 2018 Jan 31.'}, {'pmid': '25340784', 'type': 'RESULT', 'citation': 'Jones AG, Shields BM, Hyde CJ, Henley WE, Hattersley AT. Identifying good responders to glucose lowering therapy in type 2 diabetes: implications for stratified medicine. PLoS One. 2014 Oct 23;9(10):e111235. doi: 10.1371/journal.pone.0111235. eCollection 2014.'}], 'seeAlsoLinks': [{'url': 'http://www.diabetesgenes.org', 'label': 'Research group website'}]}, 'descriptionModule': {'briefSummary': "Type 2 diabetes is a major and rapidly increasing health problem worldwide. Keeping the blood glucose (sugar) from going too high helps prevent complications. Recently a number of new treatments (collectively called 'incretin based' treatments) to lower blood glucose have become available but response is very variable and it is difficult to predict which will work for an individual. The investigators want to see if we can identify whether the new treatments are likely to be effective for an individual patient. Identifying the right treatment would improve control and minimise the side-effects and costs from ineffective treatments. We will collect blood (for measures of blood glucose, insulin secretion and genetics information), urine (for a simple measurement of insulin secretion) and other clinical information (such as weight,age, duration of diabetes and medication) in people who are about to start these new 'incretin based' treatments and assess their response over the first 6 months of treatment. We will analyse this information to see if we can predict treatment response.\n\nStudy Hypothesis:\n\nThe investigators hypothesise that those who have low insulin secretion, as measured by post meal urine C-peptide Creatinine Ratio or blood C-peptide, will have poor blood glucose response to incretin based treatments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 Diabetes commencing DPP-IV inhibitors or GLP-1 agonsists in primary or secondary care in England', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A clinical diagnosis of type 2 diabetes mellitus where the patient's clinician has determined the need for a DPP-IV inhibitor or GLP-1 analogue as a result of inadequate glycaemic control\n* HbA1c \\>= 58mmol/mol\n\nExclusion Criteria:\n\n* Treatment with DPP-IV inhibitors or GLP-1 analogues prior to study initiation (within the previous 3 months)\n* Renal failure as shown by a eGFR (estimated glomerular filtration rate) less than 30 mL/min/1.73m2"}, 'identificationModule': {'nctId': 'NCT01503112', 'acronym': 'PRIBA', 'briefTitle': 'Predicting Response to Incretin Based Agents in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Royal Devon and Exeter NHS Foundation Trust'}, 'officialTitle': 'Does Urinary C-peptide Creatinine Ratio Predict Response to Incretin Based Agents in Type 2 Diabetes', 'orgStudyIdInfo': {'id': '11233581'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients starting incretin treatments', 'description': 'Patients starting GLP-1 agonists or DPPIV inhibitors as part of their normal clinical care.', 'interventionNames': ['Other: No intervention, observational study']}], 'interventions': [{'name': 'No intervention, observational study', 'type': 'OTHER', 'armGroupLabels': ['Patients starting incretin treatments']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TR13HD', 'city': 'Truro', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Cornwall and Isles of Scilly NHS Primary Care Trust', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'zip': 'EX314JB', 'city': 'Barnstaple', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'North Devon NHS Trust', 'geoPoint': {'lat': 51.08022, 'lon': -4.05808}}, {'zip': 'EX25DW', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter NHS Foundation Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'PL68DH', 'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Plymouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'TQ27AA', 'city': 'Torbay', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'South Devon Healthcare NHS Foundation Trust'}, {'zip': 'BA228HR', 'city': 'Taunton', 'state': 'Somerset', 'country': 'United Kingdom', 'facility': 'Taunton and Somerset NHS Foundation Trust.', 'geoPoint': {'lat': 51.01494, 'lon': -3.10293}}, {'zip': 'BA21 4AT', 'city': 'Yeovil', 'state': 'Somerset', 'country': 'United Kingdom', 'facility': 'Yeovil Disctrict Hospital NHS Foundation Trust', 'geoPoint': {'lat': 50.94159, 'lon': -2.63211}}, {'zip': 'BH7 7DW', 'city': 'Bournmouth', 'country': 'United Kingdom', 'facility': 'The Royal Bournmouth and Christchurch Hospitals NHS Trust'}, {'zip': 'BS10 5NB', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'North Bristol NHS Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'IP4 5PD', 'city': 'Ipswich', 'country': 'United Kingdom', 'facility': 'Ipswich Hospital NHS Trust', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'zip': 'NN15BD', 'city': 'Northampton', 'country': 'United Kingdom', 'facility': 'Northampton General Hospital NHS Trust', 'geoPoint': {'lat': 52.25, 'lon': -0.88333}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Radcliffe Hospitals NHS Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'PO6 3LY', 'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Portsmouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'zip': 'RH1 5RH', 'city': 'Redhill', 'country': 'United Kingdom', 'facility': 'Surrey and Sussex Healthcare NHS trust', 'geoPoint': {'lat': 51.24048, 'lon': -0.17044}}, {'zip': 'TN37 7RD', 'city': 'Saint Leonards-on-Sea', 'country': 'United Kingdom', 'facility': 'East Sussex Healthcare NHS Trust', 'geoPoint': {'lat': 50.85565, 'lon': 0.5452}}, {'zip': 'ST4 7LN', 'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'University Hospitls North Staffordshire NHS Trust', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'zip': 'CV34 5BW', 'city': 'Warwick', 'country': 'United Kingdom', 'facility': 'South Warwickshire NHS Foundation Trust', 'geoPoint': {'lat': 52.28333, 'lon': -1.58333}}, {'zip': 'WD18 0HB', 'city': 'Watford', 'country': 'United Kingdom', 'facility': 'West Hertfordshire Hospitals NHS Trust', 'geoPoint': {'lat': 51.65531, 'lon': -0.39602}}], 'overallOfficials': [{'name': 'Andrew T Hattersley', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Exeter Medical School/Royal Devon and Exeter Hospital NHS Foundation Trust'}, {'name': 'Angus Jones', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Exeter Medical School/Royal Devon and Exeter Hospital NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Devon and Exeter NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'University of Exeter', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'NIHR Doctoral Research Fellow', 'investigatorFullName': 'Angus Jones', 'investigatorAffiliation': 'Royal Devon and Exeter NHS Foundation Trust'}}}}